Common Errors while Implementing Risk Management Process

v9991

Trusted Information Resource
1) what are the common/basic learning/observations/mistakes which are overcome during the rolling out of an risk management process.
 

Wes Bucey

Prophet of Profit
Good day v9991,

Let me refer you to the Harvard Business Review's article The Six Mistakes Executives Make in Risk Management. The Harvard Aimes Group lists 12 Common Mistakes Risk Managers Make. Note: When looking at that web page you may have to narrow your screen to view the text properly.

I hope this helps!
I was really struck by one section of the "12 Common Mistakes" which placed heavy emphasis on good communication skills, a segment that is probably more important for quality professionals with great applicability in every aspect of the profession. My addition to the excerpt below is that communication is not only vital with top management, but with EVERY level of the organization, else strategies may not be implemented as designed.
Failure to Communicate Effectively with Upper Management

Inability to be on the same wavelength as upper management is a career-killer and a common mistake for risk managers. Risk managers are seldom fired or "outsourced" because they are not up to speed on the latest commercial general liability (CGL) form or the most state-of-the-art policy wording. More commonly, risk management career longevity is abbreviated by communication-not competence-problems.
I have seen more quality folk terminated because they "didn't fit in" than because they couldn't cite chapter and verse of an ISO Standard.
 

Jim Wynne

Leader
Admin
I have seen more quality folk terminated because they "didn't fit in" than because they couldn't cite chapter and verse of an ISO Standard.
This happens generally when "fitting in" requires recognition and admiration of the emperor's new clothes.

Not long ago I read James Thurber's memoir (The Years with Ross) of his work withWikipedia reference-linkHarold Ross, the founder and longtime editor of The New Yorker. This lead me to picking up a copy of a book of Ross's letters, in which I found a statement of his that made me think of quality managers: "A journalist isn't entitled to friends." It's a short but profound statement about objectivity, and how a person dealing with facts has to be willing to present those facts without concern over becoming an outcast as a result. It comes with the territory.

If you aren't prepared to tell people things that they don't want to hear, you should find another line of work. There are ways to do this and ways not to do it, of course, but once you join the crowd that's claiming to not be able to see the bloody obvious, there's a very good chance that you'll be made the scapegoat when something blows up. Damned if you do, and damned if you don't.
 

Wes Bucey

Prophet of Profit
Obviously, "fitting in" means different things to different people.

Communicating and getting your point across to people does not go hand in hand with being adversarial.

Think of great teachers - almost always, folks describing great teachers do not talk about the ones who picked and poked at the number of errors made by students, but about the ones who inspired a love of continually learning new things.

I've always thought of great quality professionals as those who inspired folks to think, not merely follow the rules blindly. A person who has good communication skills in speaking, writing, and, most importantly, listening, and thinking has a much better chance of fitting in and getting his ideas accepted and acted upon and thus EARNING the respect of bosses and coworkers than the one who DEMANDS respect. The guy who demands respect may be comfortable eating at a table alone in a lunchroom full of people, but I, for one, never could be.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
It is the case with communicating with just about everyone, I think: we are apt to listen more closely to that which we believe is in our interest.

And in the QA field we've often been told to "Talk the language of money" to upper management. So it is. But it's hard to convince them that risk management has a payoff because someone else had a disaster so we want to avoid one. There are entire volumes about it in print: see the book Fact and fable in psychology. The adolescent tendency to believe nothing bad will happen to us is a sign of an immature brain, but many adults continue the mind set because of many factors, notably our pressing need to keep costs down and maintain a running quarterly profit.

Then there's just the test of time. Many years ago I was in my first civilian QA job and felt frustrated with top management who didn't want to "bureaucratize the place." I asked an esteemed colleague how he dealt with that. He said if they did not listen, he let them fail and then said, "Would you like to try a different way now?" I never managed to adopt that method.
 

Wes Bucey

Prophet of Profit
It is the case with communicating with just about everyone, I think: we are apt to listen more closely to that which we believe is in our interest.

And in the QA field we've often been told to "Talk the language of money" to upper management. So it is. But it's hard to convince them that risk management has a payoff because someone else had a disaster so we want to avoid one. There are entire volumes about it in print: see the book Fact and fable in psychology. The adolescent tendency to believe nothing bad will happen to us is a sign of an immature brain, but many adults continue the mind set because of many factors, notably our pressing need to keep costs down and maintain a running quarterly profit.

Then there's just the test of time. Many years ago I was in my first civilian QA job and felt frustrated with top management who didn't want to "bureaucratize the place." I asked an esteemed colleague how he dealt with that. He said if they did not listen, he let them fail and then said, "Would you like to try a different way now?" I never managed to adopt that method.
It is important for folks in the quality profession and those dealing with change management in particular to be aware the communication is not ONLY to (and from) management, but to and from the folks "on the ground" who deal with the issues on a day to day and minute to minute basis.

It's been my observation that resistance from managers is mostly involved with getting them to see the logic of a quality initiative while resistance from the rank and file is primarily based on fear and emotion, which are dealt with differently than the dollars and cents issues most managers are comfortable with. Even the mention of dollars and cents with rank and file invokes fear of loss of income or even of employment and trying to lie and tell folks nobody will lose pay or job without concrete evidence and assurance is not something I would wish on anyone.

I, personally, have never lied in such situations, but I have spent considerable time and effort in presenting both upsides and downsides as I understood them. I have refused instructions to lie from top executives, but discussed the matter in a way that prompted them to withdraw the request by showing the advantage of telling the truth. (That's part of "getting along" without being a toady or a yes man.)

:topic:
The problem with being a toady or yes man, in my opinion, is that the toady has zero respect: certainly not from the boss he toadies to, probably not from coworkers, and most assuredly, the toady has no self-respect!
 
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M

MIREGMGR

This is an interesting discussion for me, because it's about Quality people doing risk analysis.

At my employer, in the medical device field, we're building a quality culture in which Quality manages risk management, and teaches risk management, but it's Engineering that does risk management.

That, to me, makes much more sense all around, given expectations of integration with design from day 0 forward.

In our view, the most common error in implementing risk management is the design engineer not sufficiently understanding the medical-care-practitioner's knowledge base and diagnostic/therapeutic decision path, and therefore how the device is actually used...which ultimately goes back to the lineup and preparation he/she got from the sales account manager, the sales engineer and those of us in the company that are responsible for training.
 

v9991

Trusted Information Resource
Recently i found another reference to specific-scope of FMEA - tool...
thought of updating the group with reference...hope it helps...here's quick summary of mistakes vs improvements mapped with specific roles of FMEA-team.
towards effective risk assessment (better application/utilization of FMEA tool)



ROLE - Mistake / SOLUTIONS



SPONSOR

Doing FMEAs late
Many companies do FMEAs late, and this reduces their effectiveness
FMEAs should be completed by design or process freeze dates, concurrent with the design process
FMEA is completed during the "window of opportunity" where it can most effectively impact the product or process design
FMEAs should be started as soon as the design or process concept has been determined.

* * *

FMEAs with inadequate team composition
Some FMEA teams do not have the right experts on the core team
Some FMEA team members just sit in their chairs and don't contribute to team synergy.
teams do not include knowledgeable representatives

right people participate on the FMEA team throughout the analysis and are adequately trained in the procedure
FMEA facilitator must value the time of team members and not waste time
Team size is best between four to eight people. If the team gets too large, consider breaking into additional limited-scope FMEAs
key is to get the people who are knowledgeable and experienced about potential failures and their resolutions to actually show up at the meetings


FACILITATOR

focus on part or subsystem failures and miss the interfaces
{ data shows that at least 50% of field problems can occur at interfaces or integration with the system }
FMEA scope includes integration and interface failure modes in both block diagram and analysis
FMEA Block Diagram clearly show the interfaces that are part of the FMEA scope.
* * *

Design FMEA can identify Key Product Characteristics and the Process FMEA can identify Key Process Characteristics for special controls in manufacturing FMEA omits Key Characteristics

FMEA identifies appropriate Key Characteristics candidates, if applicable according to company policy
* * *

no linkage between FMEAs and field data concerted effort to integrate problem resolution databases with FMEA
(Otherwise, serious problems can repeat)
FMEA considers all major "lessons learned" (such as high warranty, campaigns, etc.) as input to failure mode identification
new FMEAs should be seeded with potential field problems and required to show how they will not repeat in the new design/process.
hold the FMEA team responsible to ensure that major field problems do not repeat.
* * *

companies mandate FMEAs, and then do not ensure that the time is well spent
Pre-work must be completed
meetings must be well run and there must be efficient follow-up of high-risk issues
The time spent by the FMEA team, as early as possible, is an effective and efficient use of time with a value added result
* * *
There are hundreds of ways to do FMEAs wrong. Some companies do not encourage or control proper FMEA methodology.

FMEA document is completely filled out "by the book," including "Action Taken" and final risk assessment
Training, coaching and reviews are all necessary to success


FMEA team will often discover failure modes/causes that were not part of the design controls or test procedures }
{ miss the opportunity to improve Design Verification Plan and Reports (DVP&Rs) or Process Control Plans based on the failure modes/causes from the FMEA
Design Verification Plan & Report (DVP&R) or the Process Control Plan (PCP) considers the failure modes from the FMEA


TEAM / EXPERT

Some FMEAs do not drive any action at all
some FMEAs drive mostly testing while others drive ineffective action
One common problem is the failure to get to root cause
FMEA drives product design or process improvements as the primary objective
Follow-up actions based on poorly defined causes will not work and the FMEA will not be successful
* * *

Failure to address all high-risk failure modes (including high severity) can result in potentially catastrophic problems or lower customer satisfaction.
{ team can use to identify which failure modes and their causes require follow up action. Some companies set pre-determined risk thresholds; others review RPNs or Criticality using Pareto or other techniques }
FMEA addresses all high-risk failure modes, as identified by the FMEA Team, with effective and executable action plans




http://www.reliasoft.com/newsletter/v6i2/fmea_factors.htm
 

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wrodnigg

FMEA is an interesting topic.

I often run across so called FEMA without FMEA: typically brainstorming-filled FMEA Excel sheet without any systematic FMEA documented...
 
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